The following article is part of coverage from the American Academy of Neurology’s Annual Meeting (AAN 2020). Due to the global COVID-19 pandemic, the Academy made the necessary decision to cancel the meeting originally scheduled for April 25–May 1, 2020, in Toronto. While live events will not proceed as planned, readers can click here catch up on the latest research intended to be presented at the meeting.
In patients with relapsing multiple sclerosis (MS), ponesimod was found to be superior to teriflunomide on annualized relapse rate, fatigue symptoms, MRI activity, brain atrophy and no evidence of disease activity (NEDA) status, with no difference on confirmed disability accumulation , according to study results intended to be presented at the annual meeting of the American Academy of Neurology (AAN 2020).
Ponesimod is an oral highly selective and reversible modulator of sphingosphine-1 phosphate (S1P1) receptor used for MS. Ponesimod can reduce peripheral lymphocyte counts and prevent lymphocyte recruitment to inflammation sites. The goal of the current study was to compare the efficacy of ponesimod with teriflunomide in patients with relapsing MS.
OPTIMUM (ClinicalTrials.gov Identifier: NCT02425644) was a multicenter, randomized, double-blind active-controlled, superiority phase 3 study that included 1133 participants aged 18-55 years with relapsing MS and expanded disability status scale score of 0-5.5. The participants were randomized to ponesimod 20 mg or teriflunomide 14 mg once daily for 108 weeks.
The primary efficacy outcome was annualized relapse rate and the secondary endpoints included fatigue-related symptoms: fatigue symptom and impact questionnaire-relapsing MS [FSIQ-RMS], combined unique active lesions per year, time to 12-week and 24-week confirmed disability accumulation. The researchers also assessed the percent change in brain volume and NEDA-3 status.
Ponesimod was superior to teriflunomide on annualized relapse rate (0.202 vs 0.290, relative rate reduction [RRR] 30.5%, P =.0003), mean change from baseline to week 108 in FSIQ-RMS weekly symptoms score (0.01 vs 3.57, P =.0019), mean number of CUALs per year on MRI (1.405 vs 3.164, RRR 56%, P <.0001).
Time to 12-week and 24-week confirmed disability accumulation risk estimates were reduced by 17% (10.1% with ponesimod vs 12.4% with teriflunomide, P =.2939) and 16% (8.1% with ponesimod vs 9.9% with teriflunomide, P =.3720), respectively. At week 108, brain volume loss was -0.91% vs -1.25%, respectively and NEDA-3 was achieved in 25.0% vs 16.4% patients, respectively (odds ratio 1.70, P =.0004).
“Ponesimod was superior to teriflunomide on [annualized relapse rate], fatigue symptoms, MRI activity, brain atrophy and NEDA with no significant difference on 12-week and 24-week [confirmed disability accumulation] estimates”, conclude the researchers.
Fox R, Kappos L, Burcklen M, et al. Efficacy outcome measures of oral ponesimod compared to teriflunomide in patients with relapsing multiple sclerosis: results of the randomized, active-controlled, double-blind, parallel-group phase 3 OPTIMUM study. Intended to be presented at the 2020 annual meeting of the American Academy of Neurology.
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